MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Model Number DL900F

Device Problems Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary:the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.The apex of the filter overlay the level of the interspace.Approximately five days of post deployment, computed tomography of chest revealed a large right main pulmonary artery embolism.It also showed that the filter had cranially migrated and tilted.Around three days later, computed tomography of abdomen and pelvis showed confirmed tilt of the filter with its apex in the central right renal vein.It showed extensive iliocaval thrombosis up to the inferior vena cava filter.Around one month later, ultrasound lower extremity showed tilt of the inferior vena cava filter with apex in the central right renal vein.Iliocaval thrombosis below the inferior vena cava filter.Around three months later, computed tomography venogram of abdomen and pelvis with contrast showed that there was an infrarenal denali inferior vena cava filter which appeared adhesed, tilted with hook of the filter partially protruding within the right renal vein and one of the legs protruded medially likely resulted in inferior vena cava perforation.There was a chronic thrombus seen below the filter which extended from peripheral inferior vena cava to involve the right common and left external iliac veins.No pulmonary embolism noted in the visualized pulmonary arteries.A preliminary fluoroscopic image of the abdomen demonstrated a filter in the lower abdomen which was partially collapsed and with a rightward caudocranial angulation.Around six months later, filter retrieval attempt was performed.Using ultrasound guidance, the right internal jugular vein was accessed with a 21 gauge needle from a low posterior approach.A 5 french pigtail catheter was advanced into the suprarenal inferior vena cava terminated immediately above the inferior vena cava filter.After dilation, the 11 fr sheath was placed over the amplatz guidewire.The hook at the apex of the filter was captured using a 25 mm amplatz nitinol snare, and the 11 fr sheath was partially advanced over the filter.The filter was removed in its entirety.There was no extravasation from the inferior vena cava after filter removal.Gross description demonstrated that the specimen consisted of a grossly intact blood-tinged silver metallic umbrella-like inferior vena cava filter measured 5.5 x 4.5 x 3.5 cm.Therefore, the investigation is confirmed for filter migration, filter tilt, perforation of inferior vena cava (ivc), and material deformation.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 02/2021).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted, migrated and partially collapsed.The device was removed percutaneously.The patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12126950
• MDR Text Key: 260214376
• Report Number: 2020394-2021-80542
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFCN1595
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(6), ELIQUIS, COLACE, KEPPRA; DOCUSATE, LEVETIRACETAM AND NORTRIPTYLINE; PAMELOR, APIXABAN, ACETAMINOPHEN
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR